Infection Control Division | Hygiene Indicators Rev.11 / 12.

2018 Page 3 de 6 EN

PRO1 MICRO
Hygiene Monitoring System.
High sensitivity pen system for the detection
and quantification of surface proteins and
allergens.
Usage
Designed to detect and quantify proteins, allergens and reducing agents
with high sensitivity on surfaces and difficult-to-access areas after the
cleaning process.
Applicable Regulation
ISO 15883-1: 2006 / HTM 01-01: 2016 / HTM 01-05: 2013.
Characteristics
•The system consists of a reactive solution and a high absorption swab,
which allows the collection of samples from different types of surfaces
with the same efficiency.
•Pen diameter: 12,4 mm; Pen length: 163,6 mm; Swab length: 107,2 mm.
•Detection limit: 1 μg.
•Sensitivity: 0.3 μg.
•Qualitative analysis: Incubate using the Bionova® IC10/20 incubator
(temperature: 60± 2º C; 15 minutes). When comparing the color
obtained in the solution of the pen with the reference color guide, a
visual estimation of surface cleaning can be made.

OK - Clean, no further actions required.

Warning! - Re-clean.
x/xx - Re-clean and re-test.

•Quantitative analysis: Using the Bionova® IC10/20FR, Bionova®

IC10/20FRLCD or Bionova® MiniPro auto-reader incubators. Read the
instructions for use of the device previously.
Incubation time: using the Bionova® IC10/20FR or the Bionova®
IC10/20FRLCD auto-reader incubators: 15 minutes; using the Bionova®
MiniPro auto-reader incubators: 10 minutes.
Incubation range: 60± 2 ºC.

Environmental conditions during manufacture

15-30 ºC (room temperature), RH 30-80 %.

Storage conditions
T = 2-30 ºC, RH 30-80 %, store in dark place.

Transportation conditions
Storage conditions should be strictly followed.
Transport in closed and strengthened boxes in order to avoid damages.
Transportation of this product does not represent a risk for health.
Product can be kept at temperature below 25 ºC for up to 25 days
during transportation without modifying its shelf-life (provided that the
subsequent storage conditions are respected).
Infection Control Division | Hygiene Indicators Rev.11 / 12.2018 Page 4 de 6 EN

Shelf-life
24 months when stored refrigerated (4°C) and 6 months when stored
at room temperature (up to 25°C).

Packing
Boxes with 100 pens + 1 swab moisturizer, boxes with 20 pens + 1
swab moisturizer or foil bags with 8 pens + 1 swab moisturizer
(sample).
Packing information: product code and description, manufacturer
information and data on label.

Labelling
On product: product code and description, reference color guide,
batch number, manufacture and expiration date and datamatrix code.
On product´s box: product code and description, batch number
manufacture and expiration date, bar code and datamatrix code.

Possible target markets

Healthcare, Food, Pharmaceutical and Medical industries.

Other important information

Read product’s instructions for use thoroughly before use.

Description of identified and/or predictable risks

which could represent a risk for the product
Do not reuse.
Do not open until its use.
Do not touch the swab with your hands. Wear gloves, surgical mask
and other hygiene measures.
Do not freeze.
High concentrations of alkaline sanitizers may cause false negative
results in some cases. Hydrogen peroxide based disinfectants may
cause a false positive color change reaction.